Neutrophil, Lymphocyte and Platelet as a Predictor for AKI and Mortality

Acute Kidney Injury Clinical Trial

Official title:

Risk Factor of Acute Kidney Injury After Open Heart Surgery With Cardiopulmonary Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02916043
• Other study ID #: 1604-038-753
• Status: Completed
• Phase: N/A
• First received: September 25, 2016
• Last updated: November 13, 2016
• Start date: April 2016
• Est. completion date: November 2016

Study information

• Verified date: September 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Cell-count related risk factors for acute kidney injury after cardiovascular surgery have been reported. The authors attempted to investigate whether the perioperative cell counts of neutrophil, lymphocyte, platelet are associated with the postoperative acute kidney injury and long-term mortality after cardiovascular surgery using cardiopulmonary bypass.

Description:

Acute kidney injury (AKI) after cardiovascular surgery remains a serious complication associated with increased mortality for up to 10 years. The incidence of AKI after cardiovascular surgery is as high as 55% and the incidence of renal replacement therapy (RRT) to be up to 8 %.

Cell-count related risk factors for acute kidney injury after cardiovascular surgery have been reported. The authors attempted to investigate whether the perioperative cell counts of neutrophil, lymphocyte, platelet are associated with the postoperative acute kidney injury and long-term mortality after cardiovascular surgery using cardiopulmonary bypass.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1099
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Adult patients who underwent cardiovascular surgeries with cardiopulmonary bypass (CPB), including valve replacement and surgery on the thoracic aorta at the Seoul National University Hospital between 2007 and 2015

Exclusion Criteria:

• Missing preoperative serum creatinine (sCr) values

• Missing preoperative platelet, neutrophil and lymphocyte counts

• Patients who underwent preoperative hemodialysis

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

Procedure:
• Cardiovascular surgery with cardiopulmonary bypass
Patients who underwent cardiovascular surgery including valve replacement or thoracic aortic surgery with cardiopulmonary bypass

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postoperative length of hospital stay	postoperative length of hospital stay	postoperative two month	No
Other	Postoperative length of ICU stay	postoperative length of ICU stay during postoperative two months	postoperative two months	No
Other	Postoperative incidence of complications	postoperative incidences of surgery-related complications during hospital stay	postoperative two months	No
Primary	Acute kidney injury	acute kidney injury during postoperative seven days defined by Kidney Disease Improving Global Outcomes (KDIGO) criteria	postoperative day seven	Yes
Secondary	All-cause mortality	all-cause mortality after cardiovascular surgery after postoperative seven years	postoperative seven years	Yes